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Fascilulated Nail

by The Deca Co.

510(k) K854227

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854227 Date4 Feb 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fascilulated Nail is a medical device classified under orthopedic orthoses, designed for the fixation and stabilization of nails, particularly in orthopedic applications. It is intended to provide support and alignment to fractured or deformed nails, aiding in the healing process.

This device is supplied as a single-use item and is regulated under FDA 510(k) clearance (K854227) with a decision of Substantially Equivalent (SESE). It is intended for use in clinical settings where orthopedic nail stabilization is required, adhering to traditional review standards. No additional sterility, MRI safety, or reusable specifications are noted in the regulatory data.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Fascilulated Nail designed to do in clinical practice?

    The Fascilulated Nail is specifically designed for orthopedic applications to provide fixation and stabilization of nails, particularly in cases of fractures or deformities. It helps support and align the nail during the healing process, ensuring proper positioning while the bone or nail recovers.

  • Is the Fascilulated Nail intended for reuse, or is it meant to be used only once?

    The Fascilulated Nail is explicitly supplied as a single-use item, meaning it is intended for one-time clinical application only. This design ensures patient safety and sterility standards are maintained.

  • How is the Fascilulated Nail regulated by the FDA, and what does that mean for its use?

    The Fascilulated Nail is regulated under the FDA’s 510(k) clearance process with the classification K854227, determined to be *Substantially Equivalent (SESE)* to a predicate device. This means it follows traditional review standards and is approved for use in clinical settings where orthopedic nail stabilization is required, adhering to existing safety and effectiveness benchmarks.

  • Are there any special storage requirements for the Fascilulated Nail?

    The regulatory data does not specify special storage requirements beyond standard medical device handling. Since it is single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until use.